A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT07567846
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Prostate Cancer
  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GDC-1261 — DRUG
    Participants will receive GDC-1261 as per the schedule described in the protocol.

Study Details

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.

Key Dates

Start date
Apr 29, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
260 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation + Expansion
    Participants will receive GDC-1261 as per the schedule described in the protocol.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]

Central Contacts

  • Reference Study ID Number: GO46445 https://forpatients.roche.com/
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (2)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-4566-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Scottsdale, AZ

By research site
Honor Health Research Institute· Scottsdale, AZSarah Cannon Research Institute· Nashville, TN

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